Category Archives Food and Drug Administration

A group of members of Congress, led by Reps. John Joyce (R-Pa.) and Anthony Brindisi (D-N.Y.), have urged the U.S. Food and Drug Administration (FDA) to enforce "regulations defining what may be labeled a dairy product, to combat the proliferation of imitation and substitute dairy products in the marketplace that undermine FDA regulations by using standardized dairy terms on non-dairy products." "Dairy product terms convey specific information for consumers on nutritional content and ingredient performance. Put simply, imitations and substitutes do not meet these standards, nor do they have any standardized requirements for nutritional content, composition, and processing, unlike the dairy products they seek to imitate. Most importantly, they are not sourced from cows or other lactating mammals as required by the standards we referred to up above," the letter asserts. "Giving this ongoing problem, we are pleased that FDA now plans to act. We urge you to make crystal…

The U.S. Food and Drug Administration (FDA) has announced the availability of "Public Warning and Notification of Recalls," final guidance that aims to "increase and expedite the appropriate and accurate use of public warnings and public notification and to increase public health protection by better informing the public about violative products being recalled." "We’re taking a new step to help ensure appropriate public warnings and notification of recalls when FDA-regulated products are involved," FDA Commissioner Scott Gottlieb said in a statement. "The final guidance we’re issuing today outlines circumstances when a company should issue a public warning about a voluntary recall, describes the general timeframe for companies to issue such a warning, discusses what information should be included in a public warning, and describes situations where the FDA may take action to issue its own public warning should a company’s warning be deemed insufficient."

The U.S. Food and Drug Administration (FDA) has released a report detailing its investigation into a 2018 outbreak of E. coli in romaine lettuce. The report describes the FDA traceback team's investigation into farms with potential links to the outbreak that culminated in a December product recall. "The FDA continues to recommend that leafy green growers, buyer/shippers and retailers be able to trace product back to the specific source in real time and make information about the source, such as harvest date and standardized growing regions, readily available for consumers on either packaging or point of sale signs, or by other means," FDA Commissioner Scott Gottlieb said in a press release. "We’re pleased to see many companies in the leafy green industry take voluntary steps to quickly respond to our previous recommendations. We believe this is the best approach to be able to inform consumers should there be any future…

In a series of tweets, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced that about 200 food investigators—of 550—for the agency's Office of Human and Animal Food Operations have been working during the federal government's partial shutdown, with additional staff possibly "on the way depending on needs." Gottlieb further noted which food operations have continued during the shutdown: (i) "[h]igh-risk domestic food surveillance inspections"; (ii) "foodborne illness surveillance and outbreak investigations"; (iii) "[e]xecution of high-risk food recalls"; (iv) "[i]nspection of foreign food facilities"; and (v) "[s]ampling of imported food samples (including sampling for antibiotic residue contamination and decomposition analysis." High-risk foods reportedly include seafood, dairy, fresh produce, spices, eggs, sandwiches and infant formula.

Sens. Ron Wyden (D-Ore.) and Jeff Merkley (D-Ore.) have sent a letter to the U.S. Food and Drug Administration (FDA) requesting an update to federal regulations on cannabidiol (CBD) to "give U.S. producers more flexibility in the production, consumption, and sale of hemp products." Wyden and Merkley urge FDA to answer a series of clarifying questions, including "What lawful pathways are currently available for those who seek approval to introduce Cannabis sativa L. and its derivatives as a food, beverages or dietary supplement, including into interstate commerce?" and "Are there circumstances in which Cannabis sativa L. and its derivatives may be permitted as a food, beverages or dietary supplement by the agency?" “Farmers in Oregon and nationwide are poised to make real economic gains for their communities once these regulations are updated,” a press release quotes Wyden and Merkley as saying. “We will be closely engaged in the ongoing implementation…

The U.S. Food and Drug Administration (FDA) has established January 1, 2022, as "the uniform compliance date for food labeling regulations that are published on or after January 1, 2019, and on or before December 31, 2020" to help "minimize the economic impact of label changes." The agency also issued technical amendments to the Nutrition Facts Label Final Rule that correct errors in sample labels and inadvertent omissions of preexisting provisions.

The U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA) have announced after "several thoughtful discussions" that both agencies "should jointly oversee the production of cell-cultured food products derived from livestock and poultry." The agencies' statement announces a "joint regulatory framework wherein FDA oversees cell collection, cell banks, and cell growth and differentiation" that will transition "during the cell harvest stage" to USDA, which "will then oversee the production and labeling of food products derived from the cells of livestock and poultry." "This regulatory framework will leverage both the FDA’s experience regulating cell-culture technology and living biosystems and the USDA’s expertise in regulating livestock and poultry products for human consumption," the announcement concludes. "USDA and FDA are confident that this regulatory framework can be successfully implemented and assure the safety of these products. Because our agencies have the statutory authority necessary to appropriately regulate cell-cultured food products derived…

The U.S. Food and Drug Administration (FDA) has announced the seizure of human and animal food products held by J and L Grocery LLC in insanitary conditions. A complaint filed in Arkansas federal court alleges that September and October 2018 FDA inspections "revealed insanitary conditions including multiple live and dead rodents, rodent nesting, live racoons, live cats, a dead possum, animal feces, and urine-stained products in and around the company’s seven warehouses and sheds used to store food, medical products and cosmetics." “The widespread insanitary conditions found at J and L Grocery is alarming and won’t be tolerated,” a press release quoted FDA Commissioner Scott Gottlieb as saying. “At this time, we’re unaware of adverse events associated with the use of products purchased at J and L Grocery. The work of our field force and the goals of our vigorous oversight efforts are to find these kinds of potential hazards…

The U.S. Food and Drug Administration (FDA) has released several reports and guidance documents on food-related issues, including draft guidance on reasonable serving sizes and a report on foodborne illnesses in restaurants. Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics. This draft guidance details how food companies determine reasonable serving sizes for the nutritional panels on their products. Comments submitted before January 4, 2019, will be considered before FDA begins working on the final version of the guidance. Nutrition and Supplement Facts Labels: Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals; Guidance for Industry. FDA has provided a series of questions and answers on quantifying added sugars, vitamins and minerals. Several questions focus specifically on calculating added sugars in fruit juices…

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb has issued a statement announcing the agency's Plant and Animal Biotechnology Innovation Action Plan. Gottlieb describes the plan as identifying priorities in three areas: (i) "advancing human and animal health by promoting product innovation and applying modern, efficient and risk-based regulatory pathways;" (ii) "strengthening public outreach and communication regarding the FDA’s approach to innovative plant and animal biotechnology;" and (iii) "increasing engagement with domestic and international partners on biotechnology issues." The plan indicates that FDA will "adopt a comprehensive policy framework for the development and regulatory oversight of animal biotechnology products, including for intentionally genetically altered animals and the food and drug products derived from them." The statement also announced that the agency's Center for Veterinary Medicine will host a webinar on genome editing in animals on December 3, 2018.

Close